BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE

    K Number: K954718 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    15
    Review Days
    139

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    Basic Information

    Device Name
    ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
    K Number
    K954718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ellman Intl., Inc.
    Date Received
    October 13, 1995
    Decision Date
    February 29, 1996
    Product Code
    HEE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HEE Set, Anesthesia, Paracervical

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